| Trial registration number
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NCT05668065 |
Full text link
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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https://clinicaltrials.gov/show/NCT05668065
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First author
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Not reported
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Contact
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Not reported
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Registration date
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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2022-12-29
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Recruitment status
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Completed
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Study design
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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RCT
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Allocation
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Randomized
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Design
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Parallel
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Masking
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Blind label
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Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov
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multi-center
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Study aim
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Prevention
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Inclusion criteria
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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-inclusion criteria: acceptance to participate in the study. age: 18-60 years old.
-non-inclusion criteria: presence of disability (mainly mental disability). pregnancy. patients under immunosuppressive treatment or immunocompromised individuals. prior covid-19 infection.
-
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Exclusion criteria
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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occurrence of a serious adverse event (death, anaphylactic shock, ...). subjects wishing to withdraw from the study. occurrence of a sars-cov-2 symptomatic infection during the follow-up period.
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Number of arms
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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2
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Funding
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Institut Pasteur de Tunis
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Inclusion age min
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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18
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Inclusion age max
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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60
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Countries
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Tunisia
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Type of patients
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Healthy volunteers
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Severity scale
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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N/A
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Total sample size
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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199
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primary outcome
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines
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Notes
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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None
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Phase
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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Phase 3
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Arms
Last imported at : Jan. 2, 2023, noon
Source : ClinicalTrials.gov
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[{"arm_notes": "First dose of Coronavac", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "First dose of Coronavac", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
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